Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer

This study has been completed.

Sponsor:

Fox Chase Cancer Center

ClinicalTrials.gov Identifier:

NCT00350025

First Posted: July 10, 2006

Last Update Posted: March 31, 2017

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Progression Free Survival [ Time Frame: Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death. ]

Secondary Outcome Measures:

Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging [ Time Frame: Measured by CT scans after every 2 cycles of treatment (about every 8 weeks) ]

Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy

Drug: Cetuximab

Cetuximab 250mg/m2 IV weekly for each 28 day cycle.

Cetuximab with Paclitaxel

Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.

Drug: Cetuximab

Cetuximab 250mg/m2 IV weekly for each 28 day cycle.

Drug: Paclitaxel

Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.

Other Name: Taxol

Detailed Description:

This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs including paclitaxel. It has been found to be safe and can shrink other types of cancer.

This research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people live longer.

The purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.